Empower Your Medical Devices Trials
Clinical investigations generate the evidence needed to demonstrate medical device safety and performance in human subjects. Medigen Suite’s unified, cloud-based platform ensures high-quality data capture, efficient workflows, and compliance with EU MDR, IVDR, and FDA regulations.
A Unified Platform
Access all study data and platform functions through a secure, centralized web interface with single sign-on.
Accelerate Trials
From study start-up to database lock, streamline your investigations with a unified, expert-designed platform.
Regulatory Ready
Ensure compliance with EU MDR, FDA, and global standards while capturing accurate, audit-ready data.
Pilot and Early Feasibility Studies
Pilot and Early Feasibility studies form the foundation of medical device clinical investigations, involving 10–30 patients to generate initial safety and performance data. These trials are essential for identifying device modifications, refining operator techniques, and informing the design of later studies. Catchtrial EDC streamlines data collection, ensuring compliance with ISO 14155 and Good Clinical Practice (GCP), while Maptrial CTMS provides centralized oversight of site management, resource allocation, and workflow coordination.
Pivotal Trials
Pivotal trials are large-scale, statistically driven investigations involving hundreds of patients, designed to provide the clinical evidence required for EU MDR CE marking or US FDA Premarket Approval (PMA). Catchtrial EDC ensures high-quality, submission-ready data aligned with global regulatory standards, while Maptrial CTMS manages multi-site operations, offering real-time tracking, reporting, and scheduling to maintain compliance and efficiency throughout the trial lifecycle.
Post-Market Clinical Follow-Up (PMCF)
Post-Market Clinical Follow-Up (PMCF) monitors device safety and effectiveness after market entry, generating essential Real-World Evidence (RWE) across thousands of patients. Catchtrial ePRO and eCOA empower clinicians and patients to report outcomes directly, improving accuracy and engagement, while Maptrial CTMS consolidates multiple PMCF studies into a single platform, supporting lifecycle compliance, operational oversight, and continuous regulatory readiness.
